Description

Epirubicin is a semi-synthetic anthracycline antibiotic and a key chemotherapeutic agent. It is valued for its potent antitumor activity, particularly in the treatment of breast cancer, gastric cancer, and other solid tumors. This active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers, research institutions, and compounding facilities developing injectable oncology formulations. Its mechanism involves intercalating DNA and inhibiting topoisomerase II, leading to apoptosis in rapidly dividing cancer cells.

Application

• Oncological Formulations: Primary use in the manufacture of injectable chemotherapy drugs for clinical treatment.
• Breast Cancer Therapy: A cornerstone agent in adjuvant and neoadjuvant chemotherapy regimens for early-stage and advanced breast cancer.
• Gastric Cancer Treatment: Used in combination therapy protocols for advanced gastric adenocarcinoma.
• Bladder Cancer Therapy: Employed as an intravesical instillation for superficial bladder cancer.
• Ovarian & Lung Cancer: Component of combination chemotherapy for certain ovarian and small cell lung cancer cases.
• Pharmaceutical Research: Serves as a reference standard and for developing novel drug delivery systems (e.g., liposomal formulations).
• Clinical Compounding: Used by specialized pharmacies to prepare patient-specific doses.

Basic Information

Item	Details
Product Name	Epirubicin
CAS No.	56420-45-2
Molecular Formula	C27H29NO11
Molecular Weight	543.52 g/mol
Synonyms	4'-Epidoxorubicin; 4'-Epiadriamycin; 4'-Epi-DX; IMI-28; Farmorubicin; Epirubicin Hydrochloride; (8S,10S)-10-[(3-Amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyl)oxy]-8-glycoloyl-7,8,9,10-tetrahydro-6,8,11-trihydroxy-1-methoxy-5,12-naphthacenedione
EINECS	Contact for details

Quality Control

Our Epirubicin is manufactured under strict cGMP conditions, ensuring the highest standards of purity and consistency for pharmaceutical applications. Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing identity, potency, and impurity profiles. We adhere to relevant pharmacopeial standards (e.g., USP, EP) and our quality system is designed to meet the rigorous demands of global regulatory submissions.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature or as specified. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider conditions of 2-8°C. Keep the container sealed in a dry, well-ventilated place.

Specification

Item	Specification
Appearance	Orange-red powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 5.0 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.